Diagnostic Classifier for Cutaneous T-cell Lymphomas

April 4, 2022 updated by: Patrick M. Brunner, Medical University of Vienna
Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early and correct diagnosis of MF has very important implications for the patient. However, diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6 (!) years from the appearance of the first skin lesions until a diagnosis of MF can be made. For this reason, a test to distinguishing early MF from benign inflammatory conditions is urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients with MF, eczema and psoriasis, the investigators want to develop a classifier system that can distinguish early MF from benign inflammatory skin diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

MF patients need prior histopathological verification of their disease.

Eczema and psoriasis patients will be diagnosed clinically and, if necessary, on a histopathological basis.

Description

Inclusion Criteria:

  • Clinical and/or histopathological diagnosis of MF, eczema or psoriasis
  • Healthy control subjects without personal history of MF, eczema or psoriasis

Exclusion Criteria:

  • Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for systemic treatments)
  • Ongoing other treatment that might, in the opinion of the investigator, influence proteomic features of the samples to be acquired

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mycosis fungoides (MF)
Diagnostic test: Skin suction blistering and skin biopsies
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
Eczema (Atopic Dermatitis)
Diagnostic test: Skin suction blistering and skin biopsies
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
Chronic Plaque-Psoriasis
Diagnostic test: Skin suction blistering and skin biopsies
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
Healthy Control Skin
Diagnostic test: Skin suction blistering and skin biopsies
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin
Time Frame: At baseline
Proteomic multiplex assay
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Anticipated)

February 22, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

July 27, 2020

First Posted (Actual)

July 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTCL_Classifier_KLIF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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